Systems and Methods for Cable-Based Tissue Removal

ABSTRACT

Systems and methods for treating disc herniation include surgical and endoscopic access and removal of disc tissue. The tissue removal devices that may be used include flexible elongate members, such as a cable, that may be inserted into a vertebral disc and rotated to pulverize the disc material and facilitate its removal.

CROSS-REFERENCE TO RELATED APPLICATIONS

The application is a continuation of U.S. patent application Ser. No.12/509,356, filed on Jul. 24, 2009, which claims priority under 35U.S.C. §119(e) to U.S. Provisional Application No. 61/083,857 filed onJul. 25, 2008, and U.S. Provisional Application No. 61/106,858 and wasfiled on Oct. 20, 2008, and Provisional Application No. 61/223,343 filedon Jul. 6, 2009, all of which are hereby incorporated by reference intheir entirety.

BACKGROUND

Vertebral disc herniation is a common disorder where a portion of avertebral disc, a cushion-like structure located between the bones ofthe spine, bulges out or extrudes beyond the usual margins of the discand the spine. Disc herniation is believed to be the result of a loss ofelasticity of the tissue comprising the disc, and is associated withincreasing age. Disc herniation and other degenerative disc disease arealso associated with spinal stenosis, a narrowing of the bony andligamentous structures of the spine. Although disc herniation can occuranywhere along the perimeter of the disc, it occurs more frequently inthe posterior and posterior-lateral regions of the disc, where thespinal cord and spinal nerve roots reside. Compression of these neuralstructures can lead to pain, parasthesias, weakness, urine and fecalincontinence and other neurological symptoms that can substantiallyimpact basic daily activities and quality of life.

Temporary relief of the pain associated with disc herniation is oftensought through conservative therapy, which includes positional therapy(e.g. sitting or bending forward to reduce pressure on spine), physicaltherapy, and drug therapy to reduce pain and inflammation. Whenconservative therapy fails to resolve a patient's symptoms, surgery maybe considered to treat the structural source of the symptoms. Surgicaltreatments for disc herniation traditionally involve open proceduresthat require extensive dissection of muscle, connective tissue and bonealong a patient's back to achieve adequate surgical exposure. Thesesurgeries also expose the patient to a significant risk ofcomplications, due to the presence of critical neurovascular structuresnear the surgical site. For example, a discectomy procedure may be usedto decompress the herniation by accessing the affected disc and removinga portion of the disc and any loose disc fragments. To achievesufficient access to the affected disc, a portion of the lamina or bonyarch of the vertebrae may be removed, thereby increasing theinvasiveness of the procedure. When discectomy fails to resolve apatient's symptoms, more drastic measures may include disc replacementsurgery or vertebral fusion.

Fractures of the vertebrae bodies are another common disorder of thespinal column. When a vertebra fractures, the usual shape of the bonebecomes compressed and distorted, which results in pain. These vertebralcompression fractures (VCF), which may involve the collapse of one ormore vertebrae in the spine, are a common finding and result ofosteoporosis. Osteoporosis is a disorder that often becomes more severewith age and results in a loss of normal bone density, mass andstrength. Osteoporosis often leads to a condition in which bones areincreasingly porous or full or small holes and vulnerable to breaking.In addition to osteoporosis, vertebrae can also become weakened bycancer or infection.

In some instances, fractures of the vertebral bodies may be treated withsurgical removal of the vertebral body and the implantation of avertebral body replacement device. Other treatments may includevertebroplasty and kyphoplasty, which are minimally invasive proceduresfor treating vertebral compression fractures. In vertebroplasty,physicians use image guidance to inject a cement mixture through ahollow needle into the fractured bone. In kyphoplasty, a balloon isfirst inserted through the needle into the fractured vertebral body torestore at least some of the height and shape of the vertebral body,followed by removal of the balloon cement injection into the cavityformed by the balloon.

BRIEF SUMMARY OF THE INVENTION

Systems and methods for treating disc herniation include surgical andendoscopic access and removal of disc tissue. The tissue removal devicesthat may be used include flexible elongate members, such as a cable,which may be inserted into a vertebral disc and rotated to pulverize thedisc material and to facilitate its removal.

In one example, a tissue removal system is provided, comprising ahandheld housing with a power supply, an adjustment assembly and a motorconfigured to rotate at a speed of at least about 7000 rpm, an outershaft attached to the handheld housing and having a length of about 10cm to about 30 cm and an average diameter of less than about 2 mm, aninner shaft located within the outer shaft and coupled to the motor, atissue removal assembly comprising a tubular core attached to the innershaft and comprising a distal side opening and a proximal side openingspaced about 10 mm or less from the distal side opening, and a singleflexible multi-filament cable coupled to the adjustment assembly andcomprising a distal section coupled to the distal side opening of thetubular core, a proximal section coupled to the proximal side opening,and a middle section therebetween located outside of the tubular core,wherein the single flexible multi-filament cable has a retractedconfiguration and an extended configuration wherein the perpendiculardistance between the middle section of the single flexiblemulti-filament cable and the tubular core is at least about twice theaverage diameter of the tubular core. The average diameter of the outershaft may be less than about 1 mm and/or the average diameter of thetubular core may be less than about 1 mm. In some variations, at least aportion of the multi-filament cable may be extended to a perpendiculardistance of at least about 3 mm or about 5 mm with respect to thetubular core. The single flexible multi-filament cable may have ahelical configuration, which may be right-handed or left-handed helicalconfiguration, as well as a variable pitch configuration. The singleflexible multi-filament cable may interconnect a proximal and a distallinear rigid rod. and the proximal linear rigid rod may be partiallylocated in the proximal side opening and the distal linear rigid rod maybe partially located in the distal side opening. In other variations,the cable may be coated or fused with a rigid polymer coating proximallyand/or distally, or completely. The coating may be a polyimide coating.In some further examples, the tissue removal system may further comprisea steering assembly. The steering assembly may comprise a steering wiredistally coupled to a flexible region of the outer shaft.

In another example, a system for tissue removal is provided, comprisinga motor configured to rotate at a speed of at least 1000 rpm, arotatable shaft assembly coupled to the motor, wherein the rotatableshaft assembly comprises a distal coupling site and a proximal couplingsite comprising a proximal surface opening, and a flexible elongatemember, comprising a distal section coupled to the distal coupling siteof the rotatable shaft assembly and a proximal section slidablypositioned in the proximal surface opening, and a middle sectiontherebetween, wherein the flexible elongate member has a retractedconfiguration and an extended configuration wherein a perpendiculardistance between the middle section of the flexible elongate member andthe rotatable shaft assembly is greater in the extended configurationthan in the retracted configuration. The flexible elongate member maycomprise a flexible multi-filament elongate member, and in some but notall variations, the flexible multi-filament elongate member may compriseno more than about ten filaments. The proximal surface opening and thedistal surface opening may be longitudinally aligned along the shaft ormay be longitudinally offset, and may optionally further comprises agroove between the proximal surface opening and the distal surfaceopening. The groove may be straight or may be a helical groove, with aconstant or a variable pitch. The rotatable shaft assembly may alsofurther comprise a narrow segment located between the proximal surfaceopening and the distal surface opening. In some variations, theperpendicular distance between the middle section of the flexibleelongate member and the rotatable shaft assembly in the extendedconfiguration may be equal to or greater than about the average diameterof the rotatable shaft assembly, and sometimes may be equal to greaterthan about twice the average diameter of the rotatable shaft assembly.The rotatable shaft assembly may also comprise a distal penetrating tip.In some variations, the length of the flexible elongate member outsideof the rotatable shaft assembly may be different in the retractedconfiguration and the extended configuration. The distance between thedistal coupling site and the proximal surface opening may be unchangedin the retracted configuration and the extended configuration. Theflexible elongate member may also comprise at least one rigid sectionand at least one flexible section, and in some examples, may comprise atleast two rigid sections, which may be interconnected by a flexiblecable. At least one rigid section may be a linear rigid section. In somevariations, the proximal rigid rod may be located in the proximalsurface opening. The proximal rigid rod may also be located in theproximal surface opening when the flexible elongate member is in theextended configuration. In some examples, at least a portion of theflexible elongate member may comprise a grit surface with an averagegrit number in the range of about 200 to about 500. The flexibleelongate member may have a flexural modulus that is less than a flexuralmodulus of intact bony tissue, and/or less than a flexural modulus ofintact annular fibrosis tissue. In some variations, the flexibleelongate member may have a generally uniform flexural modulus along itslength. In some systems, the rotatable shaft assembly may be coupled tothe motor by a bendable driveshaft. The system may also further comprisea steering assembly configured to bend the driveshaft. In some examples,the ratio of the perpendicular distance between the middle section ofthe flexible elongate member and the rotatable shaft assembly in theextended configuration to a diameter of the rotatable shaft assembly maybe at least about 3:1 or at least about 5:1. The flexible elongatemember may comprise a polymeric coating, which may or may not comprisepolyimide.

In another embodiment, a method for treating a patient is provided,comprising inserting a cable toward a vertebral tissue region, whereinthe cable is coupled to a rotatable shaft assembly, extending the cablefrom an opening of the rotatable shaft assembly, rotating the cablearound a cable rotation axis of the rotatable shaft assembly, andwithdrawing the cable from the patient. The method may further compriseretracting the cable into the opening of the rotatable shaft assembly,pulverizing vertebral tissue rotating the cable, removing the pulverizedvertebral tissue from the patient, and/or removing the pulverizedvertebral tissue comprises suctioning vertebral tissue. Rotating thecable may comprise rotating the cable to a speed of at least about 1000rpm or about 5000 rpm or greater. The method may further compriseproviding access to the vertebral tissue region using a cannula and/orusing a surgical retractor. The vertebral tissue may comprise vertebralbone tissue and/or vertebral disc tissue and may further comprisepenetrating vertebral disc tissue with a distal tip of the rotatableshaft assembly or another instrument. The vertebral disc tissue may belocated within the annulus fibrosus of a vertebral disc, or may includethe annulus. In some examples, penetrating the vertebral disc maycomprise forming a self-sealing passageway through the wall of thevertebral disc, which may be less than about 2 mm or even less thanabout 1 mm in size. The may further comprise positioning the cablewithin the vertebral disc, and sometimes extending the cable may beperformed while at least a portion of the cable is in the vertebraldisc. Extending the cable may also be performed while at least a portionof the cable is in a nucleus pulposus of the vertebral disc. Extendingthe cable may also be performed while at least a portion of the cable isin a bony structure adjacent to the vertebral disc. Pulverizingvertebral tissue may comprise pulverizing nucleus pulposus tissue, andmay be performed without substantially damaging annulus fibrosus tissueand/or bony endplate tissue of an adjacent vertebral body. In someexamples, the method may further comprise bending the rotatable shaftassembly, and rotating the cable may be performed while the rotatableshaft assembly is bent. The method may also further comprise rotating aproximal segment of the rotatable shaft assembly about a proximalrotation axis that is different from the cable rotation axis of therotatable shaft assembly. Rotating the cable around the cable rotationaxis of the rotatable shaft assembly may occur while the rotatable shaftassembly is rotating about the proximal rotation axis. Extending thecable may comprise extending a portion of the cable to a separationdistance of at least about 3 mm from the rotatable shaft assembly, or atleast about 5 mm from the rotatable shaft assembly. Pulverizingvertebral tissue about the cable may be performed in a tissue zone thathas a diameter with respect to the rotatable shaft assembly that is atleast about 5 times greater than a diameter of the rotatable shaftassembly, or sometimes is at least about 7 times greater than a diameterof the rotatable shaft assembly.

In another embodiment, a method for treating disc herniation isprovided, comprising endoscopically visualizing a disc herniation,inserting an tissue removal device into vertebral disc tissue, whereinthe tissue removal device comprises an elongate shaft with a distalshaft segment coupled to an adjustable pulverizing member, bending theelongate shaft of the tissue removal device toward a target site withinthe vertebral disc tissue, setting the adjustable pulverizing member toa first distance from the distal shaft segment, mechanically pulverizingthe vertebral disc tissue located at about the first distance,endoscopically visualizing the disc herniation after pulverizing thevertebral disc tissue located at the first distance, adjusting theadjustable pulverizing member to a second distance from the distal shaftsegment that is greater than the first distance, mechanicallypulverizing vertebral disc tissue located about the second distance, andendoscopically visualizing the disc herniation after pulverizing thevertebral disc tissue located at the second distance. The may furthercomprise unbending the elongate shaft, and withdrawing the elongateshaft from the vertebral disc tissue.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic perspective view of a portion of a lumbar spine;

FIG. 2 is a schematic side elevational view of a portion of the lumbarspine;

FIG. 3 is a schematic superior view of a portion of a lumbar vertebraand disc;

FIGS. 4A and 4B are schematic superior views of a herniated disc duringand after treatment, respectively;

FIG. 5A is a side elevational view of an embodiment of a tissue removaldevice; FIG. 5B is a detailed cutaway view of the device in FIG. 5A.

FIGS. 6A and 6B are side elevational views of an embodiment of tissueremoval device with a rotatable elongate member in its retracted andextended configurations, respectively.

FIG. 7 depicts another embodiment of a tissue removal device with arecessed groove;

FIG. 8 depicts another embodiment of a tissue removal device with amulti-filament elongate member;

FIG. 9 depicts another embodiment of a tissue removal device;

FIG. 10 depicts one embodiment of a tissue removal device with aplurality of rigid supports;

FIG. 11 depicts another embodiment of a tissue removal device with rigidsupports;

FIGS. 12A and 12B illustrate another embodiment of a tissue removaldevice with a helically-oriented elongate member in the retracted andextended states, respectively;

FIGS. 13A and 13B are side elevational and longitudinal cross-sectionalviews of another embodiment of a tissue removal device; FIG. 13C is aside elevational view of the tissue removal device of FIG. 13A with atissue-removing cable in an extended state;

FIGS. 14A and 14B are side elevational views of another embodiment oftissue removal device in the retracted and extended configurations,respectively.

FIG. 15 is an embodiment of a tissue removal device with tapered centralregion.

FIG. 16 is an embodiment of a tissue removal device with a narrowcorkscrew region.

FIG. 17 is a detailed view of one embodiment of an optional tissuetransport mechanism;

FIGS. 18A and 18B are perspective and side elevational views of anotherembodiment of a tissue removal device; FIG. 18C is a component view ofthe tissue removal device in FIGS. 18A and 18B; and FIG. 18D is across-sectional view of the tissue removal device in 18A and 18B with aportion of the housing removed;

FIG. 19A schematically depicts one embodiment of a flexible tissueremoval device; FIG. 19B is a schematic side elevational view of theproximal end of the flexible tissue removal device of FIG. 19A with aportion of the housing removed; FIG. 19C is a detailed view of thedistal end of the flexible tissue removal device of FIG. 19A in a bentconfiguration; and

FIGS. 20A and 20B are schematic side and superior cross-sectional viewsof a steerable tissue removal device inserted into a vertebral disc,respectively.

FIG. 21A depicts the distal end of another embodiment of a tissueremoval device with a blunt tip and in an extended configuration; FIGS.21B to 21D depict various views of the tissue removal device in FIG. 21Ain the retracted configuration.

FIG. 22 illustrates the tissue removal device of FIG. 21A with anoptional viewing chamber.

FIG. 23 illustrates an embodiment of a cannula and obturator deviceusable with various access systems.

FIGS. 24A to 24C depicts one embodiment for performing vertebroplasty.

FIG. 25 schematically illustrates another embodiment of a cuttingmechanism.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 and 2 are schematic views of a lumbar region of a spine 100. Thevertebral canal 102 is formed by a plurality of vertebrae 104, 106, and108, which comprise vertebral bodies 110, 112 and 114 anteriorly andvertebral arches 116 and 118 posteriorly. The vertebral arch andadjacent connective tissue of the superior vertebra 104 has been omittedin FIG. 1 to better illustrate the spinal cord 122 within the vertebralcanal 102. Spinal nerves 124 branch from the spinal cord 122 bilaterallyand exit the vertebral canal 102 through intervertebral foramina 126(seen best in FIGS. 2 and 3) that are formed by the adjacent vertebra104, 106 and 108. The intervertebral foramina 126 are typically borderedby the inferior surface of the pedicles 120, a portion of the vertebralbodies 104, 106 and 108, the inferior articular processes 128, and thesuperior articular processes 130 of the adjacent vertebrae. Alsoprojecting from the vertebral arches 116 and 118 are the transverseprocesses 132 and the posterior spinous processes 134 of the vertebrae106 and 108. Located between the vertebral bodies 110, 112 and 114 arethe vertebral discs 132.

Referring to FIG. 3, the spinal cord 122 is covered by a thecal sac 136.The space between the thecal sac 136 and the borders of the vertebralcanal 102 is known as the epidural space 138. The epidural space 138 isbound anteriorly and posteriorly by the longitudinal ligament 140 andthe ligamentum flavum 142 of the vertebral canal 102, respectively, andlaterally by the pedicles 120 of the vertebral arches 116 and 118 andthe intervertebral foramina 126. The epidural space 138 is contiguouswith the paravertebral space 144 via the intervertebral foramina 126.

Referring to FIG. 4A, a vertebral disc 150 typically comprises an outer,multi-layer, annular band of connective tissue, known as the annulusfibrosus 152, which encases a gel-like resilient material known as thenucleus pulposus 154. The nucleus pulposus 154 acts as a shock-absorbingstructure for the forces acting on the spine. Both the annulus fibrosus152 and the nucleus pulposus 154 are elastic collagenous structureswhich, over time, may decrease in elasticity and cause the nucleuspulposus to bulge out at a weakened region of the annulus fibrosus 152,and even extrude through the annulus fibrosus 152. FIG. 4A schematicallydepicts an extrusion 156 of the nucleus pulposus 154, which haspenetrated through the wall of the annulus fibrosus 152 within anintervertebral foramen 126 and compressed a nerve 124 exiting the spine.Although the extrusion 156 remains in continuity with the remainingnucleus pulposus 154, the extrusion 156 may sometimes pinch off orseparate, resulting in the sequestration of a portion of the nucleus.

As mentioned previously, treatments of disc herniation may involveinternal access to the affected disc with removal or volume reduction ofthe disc material. This may relieve the pressure causing the bulging orextrusion to at least partially restore the profile of the disc. In FIG.4A, for example, a tissue removal device 200 has been inserted into theextrusion 156 extending out of the herniated disc 150. The tissueremoval device 200 is then actuated to break up and remove the extrudedmaterial. In some embodiments, the tissue removal device 200 may befurther inserted distally into the disc 150. Additional tissue with thedisc 150 may then be removed. As shown in FIG. 4B, after removing avolume of the nucleus pulposus 154 and relieving some of the pressurecausing the extrusion 156, the extrusion 156 was able to retract backinto the disc 150, thereby reducing the extrusion pathway 160 andrelieving compression of the spinal nerve 124. Although contralateralaccess of the herniated disc is depicted in FIG. 4A, ipsilateral accessmay also be used. Furthermore, direct tissue removal of the extrudedherniated disc may also be performed.

Devices used to remove disc tissue for discectomy or nucleotomy mayinclude lasers, discectomes, trephines, burrs, rongeurs, rasps, curettesand cutting forceps. Many of these devices have a substantialcross-sectional size, and when inserted into a disc, create an insertionchannel which substantially compromises the integrity of the annulusfibrosus at the insertion site. Thus, any remaining nucleus pulposusmaterial may extrude or herniate through the insertion site withouttaking measures to suture or otherwise close the insertion site, therebyadding complexity to the discectomy or nucleotomy procedure.

In contrast, a tissue removal device may be configured for minimallyinvasive insertion toward or into a vertebral disc without requiringsuturing, gluing or other procedures to seal or close the access pathwayinto the disc. The tissue removal device may be used for any of avariety of procedures, including but not limited to discectomy,nucleotomy, lysis of adhesions, and other tissue removal procedures inthe spine and throughout other regions of the body. FIG. 5A depicts oneembodiment of a tissue removal device 2, comprising an outer tube 4coupled to a housing 6. The static outer tube 4 covers a rotating driveshaft (not shown) that is attached to a tissue removal assembly 8. Inother embodiments, the tissue removal device 2 may lack an outer tubeand the drive shaft of the tissue removal device may be inserted into alumen of a cannula or other access device. The housing 6 contains one ormore components configured to control the tissue removal assembly 8 andother optional features of the tissue removal device 2. The tissueremoval assembly 8, examples of which are described in greater detailbelow, may be configured to cut, chop, grind, burr, pulverize, debride,debulk, emulsify, disrupt or otherwise remove tissue when rotated atvarious speeds. Emulsification includes, for example, forming asuspension of tissue particles in a medium, which may be the existingliquid at the target site, liquid added through the tissue removaldevice, and/or liquid generated by the debulking of the tissue. Optionalcomponents may include, but are not limited to, a motor configured torotate or move the tissue removal assembly, a power source or powerinterface, a motor controller, a tissue transport assembly, an energydelivery or cryotherapy assembly, a therapeutic agent delivery assembly,a light source, and one or more fluid seals. The optional tissuetransport assembly may comprise a suction assembly and/or a mechanicalaspiration assembly. One or more of these components may act through theouter tube 4 to manipulate the tissue removal assembly and/or othercomponents located distal to the housing 6, or from the housing 6directly. For example, the tissue removal device 2 further comprises anoptional port 20 that may be attached to an aspiration or suction sourceto facilitate transport of tissue or fluid out of the target site orpatient. The suction source may be a powered vacuum pump, a wall suctionoutlet, or a syringe, for example.

The housing 6 may further comprise a control interface 10 that may beused to control the power state of the tissue removal device 2,including but not limited to on and off states. In this particularembodiment, the control interface 10 comprises a lever or pivot member,but in other embodiments, control interface 10 may comprise a pushbutton, a slide, a dial or knob. In some embodiments, the controlinterface 10 may also change the motor speed and/or movement directionof the tissue removal assembly 8. A bi-directional tissue removal devicemay be provided, for example, as a potential safety feature should thetissue removal assembly 8 get lodged in a body tissue or structure. Theweb-like connective tissue that may be found in the epidural space mayget wound onto or caught up on the burr device or other tissue removaldevice. This connective tissue may be dislodged with a bi-directionaltissue removal device by reversing the direction of rotation to unwindthe tissue. The control interface 10 may be analog or digital, and maycomprise one or more detent positions to facilitate selection of one ormore pre-selected settings. In other embodiments, a separate motorcontrol interface may be provided for one or more features of the motor.In still other embodiments, control interfaces for other features of thetissue removal device may be provided.

Referring to FIGS. 6A and 6B, the tissue removal assembly 200 maycomprise at least one elongate member 202 having a proximal section 204and distal section 206, with each section coupled to a rotatable shaft208. The elongate member 202 has a retracted configuration, shown inFIG. 5A, and an extended configuration, shown in FIG. 5B. In theextended configuration, at least a portion 210 of the elongate member202 is displaced farther away from the rotatable shaft 208 than the sameportion 210 in the retracted configuration. To adjust the configurationof the elongate member 202, the proximal section 204 of the elongatemember 202 may be slid in or out of a proximal opening 212 of therotatable shaft 208 to alter the exposed length of the elongate member208 between the proximal opening 212 and a distal opening 214 (or distalattachment of the distal section 206) of the elongate member 202. Thepercentage change in the length of the elongate member 202 from itsretracted configuration to its extended configuration may be in therange of about 10% to about 60% or more, sometimes about 20% to about40%, and other times about 15% to about 20%. In some embodiments,transformation of the elongate member 202 between configurations mayinclude sliding its distal section 206 in or out of the distal opening214, in addition to or in lieu of movement between the proximal section204 and the proximal opening 212.

The tissue removal device 200 may further comprise a distal head 216with a conical configuration, as depicted in FIGS. 6A and 6B. Other headconfigurations are also contemplated, including but not limited to anovoid configuration, a dome configuration, a concave configuration, acube configuration, etc. The head 216 may be configured to penetrate ordissect body tissue, such as the annular wall of a vertebral disc, andmay be used while the rotatable shaft 208 is being rotated, or when therotatable shaft 208 is not rotated. In other embodiments, the head maycomprise multiple points or edges that may be used to cut, chop, grind,burr, pulverize, debride, debulk, emulsify, disrupt or otherwise removetissue or body structures. In still other embodiments, the head maycomprise surfaces with a grit that may be used as a burr mechanism. Thegrit number may range from about 60 to about 1200 or more, sometimesabout 100 to about 600, and other times about 200 to about 500.

The head may optionally comprise a port or aperture which may be used toperform suction or aspiration at the target site and/or to perfusesaline or other biocompatible fluids or materials to the target site.Use of saline or other cooling materials or liquids, for example, may beused to limit any thermal effect that may occur from frictional or otherforces applied to the target site during removal procedures. The salineor other materials may or may not be chilled. In other embodiments, oneor more therapeutic agents may be provided in the saline or fluid forany of a variety of therapeutic effects. These effects may includeanti-inflammatory effects, anti-infective effects, anti-neoplasticeffects, anti-proliferative effects, hemostatic effects, etc.

In some embodiments, the rotatable shaft may optionally comprise one ormore recesses or grooves on its outer surface to receive the elongatemember 202. For example, FIG. 7 depicts a single groove 218 between theproximal and distal openings 212 and 214 of the rotatable shaft 208. Thedepth and cross-sectional shape of the groove 218 may be configured topartially or fully receive the elongate member 202.

The elongate member 202 may comprise any of a variety of materials andstructures. For example, the elongate member 202 may comprise titanium,a nickel-titanium alloy, stainless steel, a cobalt-chromium alloy, apolymer (e.g. nylon, polyester and polypropylene) or a combinationthereof. The elongate member 202 may also have a monofilament ormulti-filament structure. FIG. 8, for example depicts a tissue removaldevice 300 with an elongate member comprising a multi-filament cable302. In some embodiments, a multi-filament elongate member may providegreater flexibility and/or stress tolerance than a monofilament elongatemember. A multi-filament elongate member may comprise any number offilaments, from about 2 filaments to about 50 filaments or more,sometimes about 3 filaments to about 10 filaments, and other times about5 filaments to about 7 filaments. In some embodiments, the elongatemember has a flexural modulus that is less than the flexural modulus ofbony tissue, such as the endplates of the vertebral bodies adjacent to avertebral disc. In some instances, by providing a flexural modulus thatis lower than certain body structures, damage to those body structuresmay be reduced or substantially eliminated. Thus, in some discectomy ornucleotomy procedures, a tissue removal device with an elongate memberthat has a flexural modulus that is less than the flexural modulus ofboth the bony tissue of the vertebral endplates and the flexural modulusof the annular fibrosus walls of the disc may be able to pulverize theinner tissue of a disc without damaging the adjacent walls of the discor the vertebral bone. In some examples, the flexural modulus of theelongate member may be less than about half of the flexural modulus ofintact bone or the annular fibrosis tissue, while in other embodiments,the flexural modulus of the elongate member is at least about 5 timeslower, or even at least about 10 times or 20 times lower. In someembodiments, the flexural modulus of the elongate member is generallyuniform along its exposed length or between its coupling sites on therotatable shaft. For example, in some embodiments, the flexural modulusmay not vary by more than about a 10× range along the length of theelongate member, while in other embodiments, the variation may be nogreater than a range of about 5× or about 2×.

In some variations, the elongate member (e.g., multifilament ormonofilament) of any of the variations described herein may be coated orsheathed with one or more materials. For example, the elongate membermay be coated with polyimide, parylene, silicone, or urethane, or otherpolymer, or with an adhesive. The material may or may not penetrate intoor between the filaments of a multi-filament elongate member. Thecoating may be applied by spray coating or dip coating, or other coatingmethod, for example. In other examples, the material may be providedbetween the filaments but not on the exposed outer surfaces of thefilaments, e.g. the material may be at least partially wiped or removedby air blowing from the outer surface of elongate member after sprayingor dipping. In other variations, the coating material may comprise asheath or tube that is glued or heat shrunk to the elongate member 202.In some variations, the sleeve or coating has an average thickness inthe range of about 0.001 to about 0.01 inches, about 0.002 to about0.008 inches, or about 0.003 to about 0.005 inches. The coating, sheathor tube may further comprise one or more support structures, such as ahelical L304 stainless steel wire that is partially or completelyembedded into the coating, sheath or tube, or adhered to the innerand/or outer surface of the coating, sheath or tube. The coating orsleeve may or may not cover the entire length of exposed or exposableelongate member or cable, and may also cover the unexposed portions ofthe elongate member or cable. In some variations, the coating or sleevemay be cover a portion of the proximal, middle, or distal portion of theelongate member and may be characterized as a percentage of coveragerelative to the overall exposed or exposable length of the elongatemember or cable, e.g. about 10%, about 20%, about 30%, about 40%, about50%, about 60%, about 70%, about 80%, about 90%, or about 100%.

Although the elongate member 202 may have a retracted configuration andan extended configuration, the elongate member 202 may also have anative or base configuration in which the stress acting on the elongatemember 202 is reduced compared to other configurations. This nativeconfiguration, if any, may be the retracted configuration, the extendedconfiguration, or a configuration between the retracted configurationand the extended configuration. Thus, the stress exerted on the elongatemember 202 in the native configuration may be lower in either theretracted configuration or the extended configuration, or a thirdconfiguration that is different from the retracted configuration or theextended configuration. In some embodiments, a native configuration thatis similar to the extended configuration may be beneficial because alower baseline stress acting on the elongate member 202 while in itsextended configuration may provide greater stress tolerance fromimpacting tissues or bone before stressing the elongate member 202beyond its fracture point. Although adjusting the elongate member 202 toits retracted configuration may result in greater stress acting on theelongate member 202, the stress may occur only during insertion andremoval of tissue removal device 2, and without the impact stressed thatact on the elongate member 202 during use. To produce the elongatemember 202 with a particular native configuration, the manufacturingsteps may vary depending upon the particular material or compositionused. In embodiments where the elongate member 202 comprises stainlesssteel (e.g. 304L or 316L stainless steel) or nickel-titanium alloys, forexample, a series of deformation steps and heat annealing steps may beused to form the elongate member 202 in a native, expandedconfiguration.

The elongate member 202 may have any of a variety of cross-sectionalshapes, including but not limited to square, rectangular, trapezoidal,circular, elliptical, polygonal, and triangular shapes, for example. Thecross-sectional shape and/or size may be uniform along its length, ormay vary along one or more sections. In one example, the elongate membermay have a tapered configuration, with a cross-sectional area thatdecreases from its proximal section to its distal section, or from itsdistal section to its proximal section. In some embodiments, theelongate member 202 may comprise a metallic wire or other elongatestructure with a diameter or maximum cross-sectional dimension in therange of about 0.2 mm to about 1.5 mm or more, sometimes about 0.3 mm toabout 1 mm, and other times about 0.3 mm to about 0.5 mm.

In some embodiments, the elongate member may be micropolished.Micropolishing may or may not reduce the risk of chipping or fragmentformation when used to debride harder or denser body structures ortissues. In other embodiments, the elongate member may comprise a gritsurface or a cutting edge along one or more portions of its length. Forexample, the elongate member may comprise a cutting edge with an edgeangle in the range of about 90 degrees to about 10 degrees, sometimesabout 75 degrees to about 15 degrees, and other times about 60 degreesto about 30 degrees, and still other times about 45 degrees to about 40degrees. The configuration of the elongate member surface may be thesame or different on opposing sides of the elongate member. For example,having different configuration on the leading surface compared to thetrailing surface of the elongate member, may permit changes in thecutting, chopping, debriding, or emulsifying characteristics of theelongate member 202, depending upon its direction of rotation. In otherembodiments, the leading and trailing surfaces may generally have thesame features and may have similar performance in either rotationdirection, but may also permit users to switch from one surface to theother if one surface has worn out. In still other embodiments, therotation direction may be user-selected, depending upon the relativelocation of the tissue to be removed and any critical anatomicalstructures. For example, the rotation direction may be selected suchthat if the cutting edge 58 or 60 catches on the tissue or structure,tissue disrupting element 8 will be rotated away from the criticalanatomical structure(s), if any.

As depicted in FIG. 6B, the elongate members 202 may have proximal anddistal sections 204 and 206 with generally similar lengths and generallystraight configurations, and a curved or angled middle portion 210between them. FIG. 9, however, depicts another embodiment of a tissueremoval device 310, comprising an elongate member 312 with proximal anddistal sections 314 and 316 with concave configurations and a middlesection 318 with a convex configuration. Other configurations are alsocontemplated, comprising any of a variety of linear, curved, or angledsections, and comprising symmetrical or asymmetrical configurations. Inthe embodiment depicted in FIG. 9, the longitudinal distance 320 betweenthe proximal and distal openings 322 and 324 of the rotatable shaft 326may be in the range of about 4 mm to about 30 mm or more, sometimesabout 6 mm to about 15 mm, and other times about 9 mm to about 12 mm.The longitudinal distances 328 and 330 from the proximal and distalopenings 322 and 324 to the peak displacement distance 332 of theelongate member 302, respectively, may be similar or different. In someembodiments, the distances 328 and 330 may be in the range of about 2 mmto about 20 mm or more, sometimes about 3 mm to about 10 mm, and othertimes about 4 mm to about 6 mm. The peak displacement distance 332between the middle section 318 and the rotatable shaft 326 can vary,depending upon the particular configuration of the elongate member. Theminimum displacement distance (not shown) of the middle section need notbe zero, as in embodiments where the elongate member does not fullyretract along its entire length against the rotatable shaft. In someembodiments, the displacement distance 318 may be in the range of about2 mm to about 10 mm or more, sometimes about 3 mm to about 8 mm, andother times about 4 mm to about 6 mm. In some embodiments, the peakdisplacement distance 322 may be characterized relative to thelongitudinal distance 320 or the proximal or distal distances 328 and330 to the peak distance. For example, the ratio of the peakdisplacement distance to the longitudinal distance may be in the rangeof about 0.2 to about 1 or more, sometimes about 0.3 to about 0.8, andother times about 0.4 to about 0.5. The distance 334 between the distalopening 324 of the rotatable shaft and the distal head 336 may be in therange of about 0.5 mm to about 5 mm or more, sometimes about 1 mm toabout 4 mm, and other times about 2 mm to about 3 mm. The length 338 ofthe head 336 may be in the range of about 2 mm to about 15 mm or more,sometimes about 3 mm to about 10 mm, and other times about 4 mm to about5 mm. In embodiments comprising a conical or tapered head, the angle 340of the head configuration may be in the range of about 10 degrees toabout 90 degrees or more, sometimes about 20 degrees to about 60degrees, and other times about 30 degrees to about 45 degrees.

The diameter 342 (or maximum transverse axial dimension) of therotatable shaft 326 and/or head 336 may be in the range of about 0.5 mmto about 5 mm or more, sometimes about 1 mm to about 3 mm, and othertimes about 1 mm to about 2 mm. The diameter of the shaft 326 and thehead 336 may be similar or different. The maximum cross-sectionaldimension of the proximal and distal openings may be the same ordifferent, and may be in the range of about 0.1 mm to about 1.5 mm ormore, sometimes about 0.2 mm to about 1 mm, and other times about 0.4 mmto about 0.8 mm.

The width of the groove 344 of the rotatable shaft 326, if any, may bein the range of about 0.2 mm to about 1.5 mm or more, sometimes about0.3 mm to about 1 mm, and other times about 0.4 mm to about 0.7 mm. Thewidth of the groove 344 may also be characterized as a percentage of thediameter or width of the elongate member, which may be in the range ofabout 80% to about 400% or more, sometimes about 105% to about 300%, andother times about 150% to about 200%. As mentioned previously the depthof the groove 344 may be less than, similar to, or greater than themaximum transverse dimension of the elongate member 312. In someembodiments, the groove depth or average groove depth may be in therange of about 0.2 mm to about 2 mm or more, sometimes about 0.4 mm toabout 1 mm, and other times about 0.6 mm to about 0.8 mm. In otherembodiments, the depth of the groove may be a percentage of the depth ofthe elongate member, in the range of about 20% to about 200% or more,sometimes about 50% to about 125%, and other times about 40% to about100%.

Although a single elongate member 202 is provided in the tissue removaldevice 200 depicted in FIG. 6A, other embodiments may comprise two ormore elongate members. In some embodiments, however, a single elongatemember may permit higher rotational speeds, due the reduced surface dragcompared to tissue removal devices with multiple elongate members. Inembodiments with multiple elongate members, the elongate members may bedistributed uniformly or non-uniformly around the perimeter of therotatable shaft. In some embodiments, each elongate member may have itsown proximal and distal openings, but in other embodiments, two or moreelongate members may share a proximal and/or distal opening. Theproximal and/or distal openings may be located at the same or differentlongitudinal position on rotatable shaft, and each elongate member mayhave the same or different length or configuration. The elongate membersmay be independently adjustable or adjustable in groups.

Referring to FIG. 10, in some embodiments, the elongate member 350 ofthe tissue removal device 352 may comprise other structures 354, 356 and358 attached or coupled to the flexible elongate member 350. Thesestructures may comprise any of a variety of structures, including tubes,rods, bars, cutting discs or other cutting members, beads or otherstructures. In the specific example depicted in FIG. 10, the elongatemember 352 comprises rigid sections 354, 356 and 358 alternating betweenflexible segments 360, 362, 364 and 366. One or more flexible segmentsmay also be substituted with a mechanical joint, such as a pin joint ora hinge joint. In some embodiments, the flexible elongate segments 360,362, 364 and 366 are part of a single contiguous flexible elongatemember that passes through a lumen of each rigid section 354, 356 and358 or are otherwise coupled to each rigid section 354, 356 and 358. Inother embodiments, one or more of the flexible segments 360, 362, 364and 366 are separate and interconnect only two rigid sections 354, 356and 358 or a rigid section and the rotatable shaft 368 or a structuretherein. The particular number, shape, flexibility/rigidity, lengths andlocations of the rigid segments and flexible segments may vary and neednot be uniform or symmetrical. In some embodiments, the percentage ofrigid section to flexible section along the length of the fully extendedelongate member may in the range of about 0 to about 99%, sometimesabout 50% to about 95%, and other times about 75 to about 90%. In someembodiments, the length of the flexible segment may be less than about75% of the length of the adjacent rigid segments, sometimes less thanabout 50%, and other times less than about 20% or about 10%.

In the example shown in FIG. 10, the tissue removal device 352 comprisesone rigid section 354 that is larger than the other rigid sections 356and 358. The section located at the peak displacement distance of theelongate member 350 may be a flexible segment 362 as shown in FIG. 10,or a rigid section in other embodiments. The rigid sections 354, 356 and358 are generally linear in shape, but may also be curved or angled orany combinations thereof. The elongate member 350 in FIG. 10 is alsogenerally configured to lie in a single plane in both the retracted andextended configurations, but in other embodiments, one or more rigid orflexible sections may be oriented out of plane in the retracted and/orextended configurations. As further illustrated in FIG. 10, the shaft368 may comprise a groove 369, or a region of the shaft with a narrowdiameter or axial transverse dimension, which may reduce the overallcross-sectional area of the tissue removal device 352 by permitting theelongate member 352 to protrude less when in the retractedconfiguration.

As shown in FIG. 10, the elongate member 350 in the extended state mayhave flexible sections 366 and 360 located about its proximal and distalopenings 370 and 372. In other embodiments, however, the elongate membermay have a rigid section or other structure about the proximal or distalopenings in the extended state. In FIG. 11, for example, the tissueremoval device 380 comprises a generally symmetrical elongate member 382with proximal and distal rigid members 384 and 386 interconnected by aflexible cable 388. In the extended configuration, the rigid members 384and 386 are partially located or recessed within the proximal and distalopenings 390 and 392 of the rotatable shaft 394. In some furtherembodiments, having rigid members 384 and 386 at the proximal and distalopenings 390 and 392 may reduce the tilting or bending of the elongatemember 382 with respect to the shaft 394. The degree with which theelongate member 382 is restricted may depend, for example, on the widthsof the openings 390 and 392 and the rigid member 384 and 386, thelengths 396 and 398 of the rigid member 384 and 386 outside and insidethe shaft 394, the lengths 400 of the flexible segment(s), and theoverall diameter of the shaft 394, and the degree of rigidity of therigid members 384 and 386. As further shown in FIG. 11, the shaft 394may further comprise a groove 400 or other configuration with a reduceddiameter or transverse axial dimension. At least a portion of the groove400 or configuration is located between the proximal and distal openings390 and 392, but the groove 400 or configuration may also be locatedproximal or distal to the openings 390 and 392, respectively.

As shown in FIGS. 12A and 12B, in some embodiments, the tissue removaldevice 420 may have proximal and distal openings 422 and 424 which arelocated at different circumferential locations along the longitudinallength of the rotatable shaft 426, and/or where the elongate member 428comprises at least one section having a helical, twisted or skewedconfiguration with respect to the rotatable shaft 426. FIG. 12A depictsthe tissue removal device 420 in a retracted or collapsed configuration,while FIG. 12B depicts the tissue removal device 400 in an extended orexpanded configurations. By extending the elongate member 408 throughthe proximal opening 422 of the shaft 426, the elongate member 426 maybecome axially compressed and expand radially outward from the shaft426.

The configuration of the elongate member may vary in the direction ofturning. For example, the elongate member may have a right orleft-handed spiral orientation (i.e. a clockwise or counter-clockwiseorientation). In FIGS. 12A and 12B, for example, the elongate member 428has a left-handed or counter-clockwise spiral orientation (as viewedfrom the proximal end of the tissue removal device 420). The spiralorientation of the elongate member 428 may be in the same as therotation direction of the shaft 426, or be the opposite of the rotationdirection. The spiral configuration of the elongate member 428 may becharacterized in any of a variety of ways. For example, the absolutenumber of turns may be the elongate member may be anywhere in the rangefrom about zero (e.g. a linear elongate member) to about 4 turns ormore, sometimes about a ¼ turn to about 1½ turns, and other times about½ turn to about one turn. In other embodiments, the spiral configurationmay be characterized by its rate of turning, which may be calculated asthe number of turns per millimeter or centimeter. In some embodiments,the rate of turning may be in the range of about 0.3 turns/cm to about 2turns/cm or more, sometimes about 0.7 turn/cm to about 1.5 turns/cm, andother times about 0.9 turns/cm to about 1 turn/cm. The elongate member428 may also be characterized by its pitch angle, which may be in therange of about 0 degrees to about 90 degrees, sometimes about 5 degreesto about 90 degrees, and other times about 45 degrees to about 85degrees. The spiral configuration of the elongate member may begenerally curved along its length, but may also comprise multiple linearsegments with angled or curved bends in between. The configuration ofthe spiral elongate member in the retracted and extended configurationmay vary, depending upon the flexibility of the elongate member, themanner and angle with which one or more ends of the elongate member areattached or fixed to the rotatable shaft, and the native configurationof the elongate member.

As shown in FIGS. 13A to 13C, a tissue removal device 450 with a spiralelongate member 452 may also comprise one or more grooves 454 on therotatable shaft 456. The groove 454 may facilitate seating and/orsecuring of the elongate member 452 in its retracted configuration. Ascan be seen in FIG. 13C, the spiral configuration of the elongate member452 and the groove 454 may not be uniform along the length of therotatable shaft 456. The distal groove 458 adjacent to the distalopening 460 comprises approximately a ½ turn along a longitudinaldistance that is about 50% shorter than the ½ turn of the middle groove462, while the proximal groove 464 between the middle groove 462 and theproximal opening 466 is generally linear. In some embodiments, thechange in turn rate may be in the range of about zero to about 4turns/cm or more, other times about zero to about 1 turn/cm, and othertimes about zero to about 0.5 turns/cm. In the particular embodimentdepicted in FIGS. 13A to 13C, the distal portion 468 of the elongatemember 452 remains generally wrapped around the shaft 456 in the distalgroove 458 in the extended configuration, while the proximal portion 470of the elongate member 452 bows radially outward. As can be seen in FIG.13C, in this particular configuration, the peak displacement distance472 of the elongate member 452 is located closer to the proximal opening466 of the shaft 456 than the distal opening 460. The proximal anddistal openings 466 and 460 may be oriented perpendicular to the outersurface of the shaft 456, or may be oriented at an angle or tangent withrespect to the outer surface of the shaft 456, which may reduce stressesexerted onto the elongate member 452 at the openings 460 and 466. Theedges of the groove 454 may also rounded along its length or at leastabout the openings 460 and 466. The elongate member, however, may beconfigured with a peak displacement distance located anywhere betweenthe proximal and distal openings, or even extending distal to the distalopening and/or proximal to the proximal opening. In other embodiments,the elongate member may even comprise multiple peak displacementdistances (e.g. a multi-angle, undulating or sinusoidal elongate memberin the extended configuration). In some embodiments, the peakdisplacement distance 472 is in the range of about 0.5 to about 10 timesgreater than the diameter or transverse axial dimension of the shaft456, sometimes about 1 to about 5 times greater, and other times about 2times to about 3 times greater. The longitudinal location of the peakdistance may be characterized as a relative position from the proximalto distal openings, which may be about −20% or less, about −10%, about0%, +10%, about +20%, about +30%, about +40%, about +50%, about +60%,about +70%, about +80%, about +90%, about +100%, about +110% or about+120% or more.

Referring now to FIGS. 14A and 14B, in some embodiments, the tissueremoval device 480 may comprise a shaft 482 with a narrowed region 484.At least a portion of the narrowed portion 484 may be located betweenthe proximal and distal attachments or openings 486 and 488 from whichthe elongate member 490 protrude, but in other embodiments, at least aportion of the narrowed portion 484 may be proximal or distal to theopenings 486 and 488, respectively. As depicted in FIG. 14A, thenarrowed portion 484 of the shaft 482 may facilitate a low profileretracted configuration, but may also provide additional space forsnagged tissue or adhered biological material to occupy. This may occur,for example, when the elongate member 490 in FIG. 14B is retracted intoits retracted configuration in FIG. 14A, or during a prolongedprocedure. This additional space may be beneficial when withdrawingtissue removal device from an endoscopy instrument or cannula. Asfurther illustrated in FIGS. 14A and 14B, the attachments or openings486 and 488 may have a transverse axial orientation, rather than thesurface orientation of the openings 422 and 424 of the tissue removaldevice 420 depicted in FIGS. 12A and 12B.

Although the narrowed portion 484 in FIGS. 14A and 14B has a uniformdiameter and configuration, in other embodiments, such as the tissueremoval device 492 in FIG. 15, the narrowed portion 494 may have atapered configuration with a variable diameter or configuration.Referring back to FIGS. 14A and 14B, the longitudinal axis of thenarrowed portion 494 may be co-axial with the axis of the rest of theshaft 482, but in some embodiments, the longitudinal axis may bedifferent, e.g. eccentric or variable. In FIG. 16, for example, thetissue removal device 496 comprises a narrowed portion 498 with anon-linear longitudinal axis comprising a helical or corkscrewconfiguration. Also, although this example of the tissue removal device496 has narrowed portion 498 and an elongate member 399 with the samehelical orientation, in other example, the helical orientations may bedifferent or opposite.

Referring now to FIG. 5B, the tissue removal device 2 in FIG. 5A isillustrated with a portion of the housing 6 removed to show variousinternal components. In this embodiment, the tissue removal device 2further comprises a battery 12 to provide power to the motor 14 whichdrives the tissue removal assembly 8. In other embodiments, a connectorto an external power source may be provided in addition to, or in lieuof, the battery 12. The type of battery and power provided may differdepending upon the particular power needs of the motor and/or othercomponents of the tissue removal device 2.

In some embodiments, the motor 14 of the tissue removal device 2 is a DCmotor, but in other embodiments, the motor 14 may have any of a varietyof configurations, including but not limited to an AC or a universalmotor. The motor 14 may be a torque, brushed, brushless or coreless typeof motor. In some embodiments, the motor 14 may be configured to providea rotational speed of about 500 rpm to about 200,000 rpm or more,sometimes about 1,000 rpm to about 40,000 rpm, and at other times about5,000 rpm to about 20,000 rpm. The motor 14 may act on the tissueremoval assembly 8 via the outer tube 4, or a by drive member locatedwithin the outer tube 4. In some further embodiments, a fluid seal 16may be used to protect the motor 14 and/or other components of thehousing 6 from any fluids or other materials that may be transportedthrough the outer tube 4, or through the housing aperture 18. In someembodiments, a connector or seal may be provided about the housingaperture 18 to permit coupling of the housing 6 to a trocar, anintroducer, a cannula or other tubular member into which the tissueremoval assembly 8 and the outer tube 4 are inserted. In someembodiments, the tissue removal device may be used with an introducer orcannula having an outer diameter of about 0.01 cm to about 1.5 cm ormore, sometimes about 0.1 cm to about 1 cm, and other times about 2 mmto about 6 mm.

As shown in FIGS. 5A and 5B, the tissue removal device 2 may furthercomprise a conduit 24 which may be used to connect the tissue removaldevice 2 and an aspiration or suction source. An aspiration or suctionsource may be used, for example, to transport fluid or material througha lumen or conduit of the outer tube 4 or through a tubular member inwhich the outer tube 4 is inserted. In one particular embodiment, theconduit 24 comprises a port 20 which communicates with the fluid seal 16via a length of tubing 22. The fluid seal 16 is configured to permitflow of fluid or material between the outer tube 4 and the tubing 22,while permitting movement of the outer tube 4 or a drive member thereincoupled to the motor 14. In other embodiments, the conduit 24 mayfurther comprise additional components, including but not limited to afluid or material trap, which may be located within or attached to thehousing 6, or attached to the port 20 or the tubing 22, or locatedanywhere else along the pathway from the tissue removal assembly 8 tothe suction source. In some embodiments, a separate port may be providedfor infusing or injecting substances into target site using the tissueremoval device 2. In other embodiments, the conduit 24 may be used forboth withdrawal and infusion of materials and/or fluids, or for infusiononly. Depending upon the configuration of the tissue removal device,withdrawal and/or infusion may occur at the distal end of the outer tube4, and/or through one or more openings of the tissue removal assembly 8.In other embodiments, a port may be used to insert a coagulationcatheter, an ablation catheter or other energy delivery device to thetarget site.

In some embodiments, the outer tube comprises an outer tubular memberwith at least one lumen, and an elongate drive member configured tomechanically couple the motor to the tissue removal assembly. In otherembodiments, the outer tube may contain additional members, for example,to adjust or control the configuration of the tissue removal assembly.In some embodiments, the outer tube 4 may comprise one or more lumenscontaining control wires, which may be used to manipulate thedeflections of the distal end of the outer tube. The outer tube andoptional drive members may be rigid or flexible. The outer tube may bepre-shaped with a linear or a non-linear configuration. In someembodiments, the outer tube and the components is configured to beuser-deformable, which may facilitate access to particular target sites,or may be user-steerable using a steering mechanism comprising one ormore pull wires or tension elements. In some embodiments, a stiffeningwire or element may be inserted into the outer tube to provideadditional stiffness to the tissue removal device. The length of theouter tube between the tissue removal element and the motor or housingmay vary from about 0 cm to about 30 cm or more in some embodiments,sometimes about 4 cm to about 20 cm, and other times about 10 cm toabout 14 cm.

In other embodiments, the tissue removal device may comprise a tissueremoval assembly that may be detachably attachable to the shaft of amotor or coupled to a motor. In still other embodiments, the tissueremoval device may comprise a tissue removal assembly coupled to ashaft, wherein the shaft may be detachably attachable to a motor or ashaft coupled to a motor.

In some embodiments, the housing 6 is configured with a size and/orshape that permits handheld use of the tissue removal device 2. In otherembodiments, the tissue removal device 2 may comprise a grip orstructure located about the outer tube 4 to facilitate handling by theuser, while the proximal end of the outer tube 4 is attached to abenchtop or cart-based machine, for example, or a mounted or fixedmachine. In these embodiments, the grip may or may not contain any othercomponents of the tissue removal device, such as a motor, while themachinery at the proximal end of the outer tube 4 may contain one ormore other components, such as a suction system or variousradiofrequency ablation components, for example. In some embodiments,the housing 6 may have a length of about 1 cm to about 12 cm or more,sometimes about 2 cm to about 8 cm, and other times about 3 cm to about5 cm. The average diameter of the housing (or other transverse dimensionto the longitudinal axis of the housing) may be about 1 cm to about 6 cmor more, sometimes about 2 cm to about 3 cm, and other times about 1.5cm to about 2.5 cm. The housing 6 may further comprise one or moreridges, recesses or sections of textured or frictional surfaces,including but not limited to styrenic block copolymers or other polymersurfaces.

As illustrated in FIG. 17, a tissue removal device may optionallycomprise a tissue transport assembly 68, which may be used to facilitatetransport or removal of tissue within or along the outer tube 4. In theparticular embodiment depicted, the tissue transport assembly 68comprises a helical member 70 mounted on a drive member 78 that may berotated. Actuation of the drive member 78 may mechanically facilitateproximal movement of tissue or other materials within the channel or thelumen 72 of the outer tube 4 by rotating the helical member 70. Theactuated drive member 78 will also rotate the distal burr element orother tissue removal assembly 8. In some embodiments, use of the tissuetransport assembly 68 may be performed at lower rotational speeds whentissue debulking is not concomitantly performed. When rotated in theopposite direction, the helical member 70 may be used expel or distallytransport tissue, fluid or other materials or agents from the outer tube4 or supplied to an infusion port of the housing 6.

In some embodiments, the helical member 70 may have a longitudinaldimension of about 2 mm to about 10 cm or more, sometimes about 3 mm toabout 6 cm, and other times about 4 mm to about 1 cm. In otherembodiments, the longitudinal dimension of the helical member 70 may becharacterized as a percentage of the longitudinal dimension of the outertube 4, and may range from about 5% to about 100% of the longitudinaldimension of outer tube 4, sometimes about 10% to about 50%, and othertimes about 15% to about 25%, and still other times is about 5% to about15%. Although the helical member 70 depicted in FIG. 17 rotates at thesame rate as the tissue removal assembly, due to their mounting orcoupling onto common structure, drive member 78, in other embodiments,the helical member may also be configured to rotate separately fromdrive member. For example, a helical member may comprise a helical coillocated along at least a proximal portion of the lumen of the outer tubebut is not mounted on the drive member. In this particular example, thehelical member may rotate independently of the drive member. In stillother embodiments, the helical member 70 may be mounted on the surfaceof the lumen 72 and can be used to transport tissue or substances alongthe lumen 72 by rotation of the outer tube 4, independent of the drivemember 78 or a tissue removal assembly.

Although the helical member 70 is depicted as a continuous structure, insome embodiments, the helical member 70 may be interrupted at one ormore locations. Also, the degree or angle of tightness of the helicalmember 70 may vary, from about 0.5 turns/mm to about 2 turns/mm,sometimes about 0.75 turns/mm to about 1.5 turns/mm, and other timesabout 1 turn/mm to about 1.3 turns/mm. The cross-sectional shape of thehelical member 70 may be generally rounded as depicted in FIG. 17, butin other embodiments, may have one or more edges. The generalcross-sectional shape of the helical member 70 may be circular,elliptical, triangular, trapezoidal, squared, rectangular or any othershape. The turn tightness and cross-sectional shape or area of thehelical member 70 may be uniform or may vary along its length. In someembodiments, multiple the helical members 70 may be provided in parallelor serially within the outer tube 4.

In some embodiments, the drive member 78 may be configured to extenddistally and retract from the outer tube 4 by a length of about 0.01 cmto about 2 cm or more, sometimes about 0.02 cm to about 1.5 cm and othertimes about 0.05 to about 1 cm. In some embodiments, the helical member70 is located proximal to the tissue removal assembly at a distance ofabout 0.01 cm to about 2 cm or more, sometimes about 0.02 cm to about1.5 cm and other times about 0.05 to about 1 cm. In some embodiments,when drive member 78 is maximally extended from outer tube 4, helicalmember 70 may protrude from outer tube 4 by a longitudinal dimension ofabout 0.01 cm to about 2 cm or more, sometimes about 0.1 cm to about 1cm, and other times about 0.25 cm to about 0.5 cm. In some embodiments,the degree of extension of the drive member 78 and/or the helical member70 may affect the degree of tissue transport by the tissue transportassembly.

Referring to FIGS. 18A and 18B, in another embodiment, a tissue removaldevice 500 comprises a housing 502 and an outer shaft 504. The housing502 may include an adjustment mechanism with a thumbwheel 506 configuredto adjust the retraction and extension of extendable tissue removalassembly (not shown). The thumbwheel 506 may provide a continuous rangeof change to extendable tissue removal assembly, but in otherembodiments, the turning of thumbwheel 506 may be configured with clicksor detents that provide one or more preset positions. As mentionedpreviously, any of a variety of other control mechanisms and interfacesmay be used. The adjustment mechanism may comprise one or more blockingelements or other adjustment limiting configurations to resist orprevent overextension of extendable tissue removal assembly. Forexample, limit structures may be provided in housing 502 to resistoverextension of extendable tissue removal assembly (not shown). In thisparticular embodiment, tissue removal device 500 is configured to rotatethe tissue removal assembly at a fixed rotational speed, controllable bya rocker-type power switch 508. As mentioned previously, however, any ofa variety of power and/or speed control mechanisms may be used.

Referring to FIGS. 18C and 18D, FIG. 18C is a component view of theinternal components within housing 502, while FIG. 18D is a schematiccross-sectional view of the internal components with a portion ofhousing 502 removed. As shown in FIG. 18C, a drive member 510 rotatablyresides within the outer shaft 504 of the tissue removal device 500. Thedistal end (not shown) of the drive member 510 is coupled to the tissueremoval assembly (not shown), while the proximal end 512 of the drivemember 510 is coupled to the distal end 514 of a driveshaft 516. Theproximal end 518 of the driveshaft 516 may be coupled to a motor 520,either directly or through a coupler 522. The coupler 522 may beconfigured to permit some axial movement of driveshaft 526. The proximalend 524 of an adjustment member 526 protrudes from the proximal end 510of drive member 512 and is attached to a drive key 528. The drive key528 may comprise a flange 530 that is slidably located between theproximal and distal ends 518 and 514 of the driveshaft 516. Thethumbwheel 506 may be movably coupled to a thrust member 532 so that therotation of the thumbwheel 506 results in the axial movement of thrustmember 532. In some embodiments, the thrust member 532 may be configuredwith helical threads that are complementary to a threaded lumen of thethumbwheel 506. In other embodiments, however, the thrust member maycomprise a slide member, a pivot member or other coupling structure. Thethrust member 532 may be configured to axially slide the drive key 528through a retaining structure 534 which movably couples the thrustmember 532 to the drive key 528. The retaining structure 534 permits therotation of the driveshaft 516 by the motor 520 while also coupling theaxial movements of the thrust member 532 to the drive key 528, therebypermitting adjustment of the tissue removal assembly located at thedistal end of the shaft 504 while maintaining the ability of the drivemember 510 to rotate. The thrust member 532 may comprise a flange 536 tofacilitate retention of the thrust member 532 within the retainingstructure 534. The flange 536 may comprise one or more bearings tofacilitate rotational movement of the drive key 528 against thenon-rotating flange 536. The retaining structure 534 may also containone or more retaining bearings 538 to facilitate the rotation of thedriveshaft 516 against the drive key 528 while transmitting any axialforces to the drive key 528. The retaining structure 534 is optionallyprovided with one or more limiters 540, which may be used to restrictoverextension or retraction of the tissue removal assembly. A seal 542may be provided around the outer shaft 504 to protect the contents ofthe housing 502.

As illustrated in FIG. 18D, the tissue removal device 500 may be poweredusing a battery 544 that is coupled to the motor 520 using a batteryconnector 546. As depicted in FIG. 18C, battery 544 may be astandardized battery, such as a 9-volt battery, but may also be acustomized battery. Other examples of drive shafts couplings andadjustment mechanisms that may be used are disclosed in U.S. Pat. No.5,030,201, which is hereby incorporated by reference in its entirety.

In the various examples described herein, the outer tube and thedriveshaft of the tissue removal device may comprise a rigid structureand material, but may also optionally comprise at least one flexibleregion which may bend while still permitting rotation of the driveshaft.Examples of flexible driveshafts that may be used are disclosed in U.S.Pat. Nos. 5,669,926 and 6,053,907, which are hereby incorporated byreference in their entirety. In some examples, the flexible region(s)may comprise a substantial portion or all of the length of thedriveshaft and outer tube. A tissue removal device with a flexibleregion may facilitate access to certain regions of the body, such as thecentral spinal canal through an intervertebral foramen. In someexamples, the flexible tissue removal device may comprise a steeringassembly that uses one or more steering wires that are attached distalto the flexible region and manipulated by a steering member in theproximal housing. Other steering mechanisms used with catheters andother elongate instruments may also be used. In other examples, anactive steering mechanism is not provided on the flexible tissue removaldevice, but the flexible tissue removal device may be steered by anendoscopic instrument into which the tissue removal device has beeninserted. Some examples of steerable endoscopic instruments aredisclosed in Application No. 61/045,919, which is hereby incorporated byreference in its entirety.

FIGS. 19A to 19C depict one embodiment of a tissue removal device 600with a flexible region 602 and a steering assembly 604 located in thehousing 606 of the tissue removal device 600. In addition, the housing606 includes a power switch 608 which actuates the motor 610 thatrotates the driveshaft (not shown) located in the outer tube 612, and anirrigation tube 614 which may be used infuse fluid or provide suctionabout the distal end of the device 600. As shown in FIG. 19B, thesteering assembly 604 comprises a pivoting lever 616 with two arms 618and 620 protruding from the housing 606. In other embodiments, thesteering assembly 604 may comprise a single arm lever, a slider, knob orother type of actuator. The steering assembly 604 may optionallycomprise one or more springs or bias structures, which may facilitatespringback of the lever 616 once released. The steering assembly 604 mayalso optionally comprise a releasable locking mechanism to maintain thesteering assembly in a particular configuration. The locking mechanismmay be a frictional interfit or an interlocking mechanism, for example.

Coupled to the lever 616 are two steering elements or wires 622 and 624,which are slidably movable within the outer tube 614 and are distallycoupled to a distal site of the flexible region 602. The steering wires622 and 624 may be separate wires, or two segments of the same wirelooped through the lever 616. When a steering wire 622 or 624 istensioned by actuating one of the lever arms 618 and 620, the flexibleregion 602 will curve or bend. The flexible region may comprise any of avariety of flexible materials and/or flexible structures, including anyof a variety of polymeric or metallic structures. In the depictedembodiment, the flexible region 602 comprise a plurality of optionalslots 626, which may augment the bending characteristics, but in otherembodiments, an accordion-like configuration or other type of bendingconfiguration may be provided. The ends 628 of the slots 626 depicted inFIG. 19C have optional enlarged arcuate configurations, which mayredistribute at least some of the bending forces that may act of theflexible region 602 and may resist tearing or reduce any resultingdamage to the flexible region. The length of the flexible region may bein the range of about 1 mm to about 200 mm or more, sometimes about 5 mmto about 50 mm, and other times about 8 mm to about 20 mm. The width ofthe ends 628 of the slots 626, as measured in the unbent configurationalong the longitudinal axis of the tissue removal device, may be in therange of about 0.5 mm to about 4 mm or more, sometimes about 1 mm toabout 3 mm, and other times about 1 mm to about 2 mm. In still otherembodiments, the flexible region may lack a particular configuration butcomprises a flexible material that has a lower durometer than the otherportions of the outer tube. The maximum degree of bending may vary fromabout 5 degrees up to about 10 degrees or more, sometimes about 15degrees up to 25 degrees or more, and other times about 45 degrees toabout 75 degrees or more, and even about 90 degrees to about 105 degreesor more in certain embodiments. In embodiments of the tissue removaldevice having bi-direction steering from its neutral axis, the maximumdegree of bending in each direction may be the same or may be different.

As illustrated in FIG. 19C, a flexible elongate member 630 is coupled toa rotatable shaft assembly 632 comprising a reduced diameter core 634located between a proximal and distal sections 636 and 638. A piercingelement 640 may be attached to the distal end of the rotatable shaftassembly 632. The proximal and distal sections 636 and 638 each compriseoptional taper regions 642 and 644. In some embodiments, the taperregions 642 and 644 may reduce or eliminate the potential snagging ofthe elongate member 630 during retraction, or snagging of the rotatableshaft assembly 632 during its insertion or withdrawal with respect tothe vertebral disc, the epidural space, or the cannula or endoscopicdevice in which it was placed. In the retracted configurationillustrated in FIG. 19C, the elongate member 630 has a helicalorientation about the reduced diameter core 634, but may or may not becontacting the core 634.

As depicted in FIG. 19C, the exposed proximal and distal ends 646 and648 of the flexible elongate member 630 may be coupled to the rotatableshaft assembly 632 through either openings or attachment sites locatedon the circumferential surfaces of the proximal and distal ends 646 and648. Other sites where one or both ends of the flexible elongate member630 may be coupled include but are not limited to the taper regions 642and 644, if any, or any other transversely surface have at least somedegree of transverse orientation with respect to the longitudinal axisof the rotatable shaft assembly 632. Still other coupling sites mayinclude the reduce diameter core 634 and the piercing element 640.

A steerable tissue removal device may be used during some procedures toincrease the region or amount of tissue removed, compared to a rigidtissue removal device, for example. In some instances, anatomicalrestrictions or increased risks of injury may limit the range with whicha rigid tissue removal device may be manipulated. FIGS. 20A and 20B, forexample, schematically depict some of the movement axes and thepotential tissue removal zones that may be achieved with a steerabletissue removal device 650. Here, a steerable tissue removal device 650with an extendable cable 652 may be inserted into a vertebral disc 653.While the steerable tissue removal device 650 and a rigid linear tissueremoval device may translate and rotate with respect to its longitudinalaxis 654, the pivoting range 656 of the rigid portion of the outer tube658 of the tissue removal device 650 (and the corresponding structure ona rigid tissue removal device) may be substantially limited because evensmall angular movements of the outer tube 658 may be require substantialabsolute displacement of the more proximal portions of the outer tube658. This displacement, however, will be limited by the amount, thelocation and/or the compliance of the body tissues and structuresbetween the proximal end (not shown) and the distal end 660 of the rigidportion of the outer tube 658. In contrast, a tissue removal device 650with a flexible segment 662 located distally permits a range ofangulation or bending 664 from the longitudinal axis 654 of the tissueremoval device 650 without requiring substantial displacement orleveraging of the rigid portion of the outer tube 658. Thus, theflexible segment 662 may be able to reach tissue that is spaced apartfrom the longitudinal axis 654 with less physical effort, and may beeven be able to reach tissue that cannot be reached by pivoting a rigidportion of the outer tube 658.

In addition to the bending of the flexible segment 662, the steerabletissue removal device 650 may also access tissues located away from thelongitudinal axis 654 by increasing the extension of the extendablecable 652 along its extension range 665. The extension range 665 may becharacterized as a dimension that is perpendicular to the longitudinalorientation of the core section 668 to which the extendable cable 652 iscoupled. For example, a tissue removal device with a 1 mm diameter coreand configured with an extendable cable that may be adjusted to aperpendicular distance of 3 mm away from the core can remove tissue in azone that is 7 mm in at its maximum diameter (i.e. 1 mm shaft plus 2times 3 mm of the rotated elongate member). In embodiments where theextendable cable is extended to a greater degree, even greater volumesor zones of tissue removal may be achieved. Thus, by manipulating thedegree of cable extension, the volume or range of tissue removal thatmay be performed may be adjusted without requiring repositioning thetissue removal device, either by torqueing its shaft or using itssteering mechanism (if any).

Because the particular tissue removal device 650 in FIGS. 20A and 20Bpermits the actuation of the extendable cable 652 while the flexiblesegment 662 is bent by providing a flexible or bendable driveshaft (notshown), the tissue removal zone 670 may be displaced away from thelongitudinal axis 654. Furthermore, because each of the movementdescribed above may be synergistically combined with one or more othermovements, even greater larger tissue removal zones may be achieved. Forexample, rotation 672 of the bent tissue removal device 650 around thelongitudinal axis 654 by torqueing the rigid portion of the outer tube658, may achieve an even larger tissue removal zone 674. The rotation672 of the bent tissue removal device 650 may occur while the extendablecable 652 is being rotated, or when the cable 652 is not rotating. Theamount of rotation 672 may be anywhere in the range of about 1 degree toabout 360 degrees or more. Any of a variety of combinations of cableextension, flexible zone bending, and outer tube rotation andtranslation may be used to achieve the desired tissue removal.

While various flexible, steerable and rigid embodiments of the tissueremoval device may be used to remove larger volumes of tissue asdescribed above, in other embodiments, a tissue removal device may beused to perform focal debulking of tissue. For example, by utilizing thesmall profile and/or the steerable features of certain embodiments ofthe tissue removal device, the tissue removal device may be moreaccurately positioned or navigated to a specific target site in a bodystructure. In some instances, the removal of lower volumes of tissue ata specific target location may be used to achieve a desired result, incomparison to the removal of a larger volume of tissue from a generaltarget location. Furthermore, by adjusting the cable or tissue removalelement relative the shaft of the tissue removal device, the volume ofmechanical tissue removal may be adjusted relative to the shaft withoutrequiring repositioning of the shaft. By removing less disc tissue toreduce a herniation, for example, a larger amount of non-pathologic disctissue and structural integrity of the disc may be preserved. In someinstance, relatively greater preservation of the disc tissue which mayslow the rate of further disc degeneration and reherniation compared tolesser degrees of tissue preservation.

In one example, a herniated disc may be accessed and visualizedendoscopically. A steerable tissue removal device may be inserted intothe disc and steered toward the region of herniation, rather than to thecenter of the disc, for example. The extendable cable or otheradjustable tissue removal element is actuated to pulverize an initialamount of tissue at the region of herniation and removed by the auger.In some embodiments, to facilitate controlled volume tissuepulverization, the distance between the couplings of the extendablecable to its rotatable shaft may be less than about 10 mm, sometimesless than about 7 mm, and other times less than about 5 mm. Tofacilitate precise removal of the pulverized tissue, the distal suctionopening of the tissue removal device may be located less than about 10mm from the proximal coupling of the extendable cable, sometimes lessthan about 7 mm, and other times less than about 5 mm or about 3 mm.After the initial actuation of the extendable cable, the herniation isreevaluated endoscopically and the degree of cable extension may beadjusted higher in a stepwise manner and reevaluated until the desiredreduction in the herniation is achieved.

In some uses of the tissue removal device, in both steerable andnon-steerable configurations, the tissue removal zones may positionedwhereby structures such as the annulus fibrosus and the vertebral bodyendplates may be unintentionally damaged or contacted. In embodimentswhere the tissue removal device has been configured as describedpreviously to limit or avoid significant damage to these structures,greater tissue removal may be safely achieved even when the distal tipof the tissue removal device cannot be directly visualized, e.g. whenthe endoscope is located in the epidural space while the tissue removaldevice is located inside the vertebral disc.

In some instances, embodiments of the tissue removal device may becharacterized by the ratio of the maximum diameter or cross-sectionalarea of tissue removal of a rotating extended elongate member, and thediameter or cross-sectional area of the outer tube of the tissue removaldevice or the tissue pathway formed by the tissue removal device. In theexample described above, the diameter of the elongate member in itsrotating deployed configuration to the diameter of the outer tube is aratio of about 7:1. In some embodiments, this ratio is at least about3:1 or higher, but in other embodiments, the ratio is at least about 5:1or higher, or even about 10:1 or about 20:1 or higher in certainembodiments. In other examples, the tissue removal device may becharacterized by the maximum perpendicular distance that the elongatemember may be extended, or by the ratio of this distance to the diameter(or an axial transverse dimension) of the outer tube. In some examples,this ratio is at least about 3:1 or more, sometimes about 5:1 or more,or even about 7:1 or about 10:1 or more.

Examples of procedures that may be used to access the spine aredisclosed in U.S. Pat. No. 7,108,705, U.S. Pat. No. 4,573,448, U.S. Pat.No. 6,217,5009, and U.S. Pat. No. 7,273,468, which are herebyincorporated by reference in their entirety. The various embodiments ofthe tissue removal device disclosed herein may be used to perform adiscectomy or nucleotomy, but may also be used to perform any of avariety of tissue removal procedures in the spine and outside of thespine. The tissue removal device may be used in minimally invasiveprocedures as well as open surgical procedures or limited accessprocedures. These procedures may include but are not limited tointerlaminar, translaminar and intralaminar access procedures. In oneparticular embodiment, a patient may be placed into a prone positionwith a pillow or other structure below the abdomen to limit lumbarlordosis. The patient is prepped and draped in the usual sterile fashionand anesthesia is achieved using general, regional or local anesthesia.Under fluoroscopic guidance, a sharp tipped guidewire, or a needle witha guidewire may be inserted into the paravertebral space or epiduralspace from a posterior or postero-lateral location of the patient's backat a location in the range of about 5 cm to about 15 cm lateral to themidline. In some instances, guidewire insertion may be facilitated byinserting a needle into the tissue first. In alternate embodiments, ananterior procedure through the abdominal cavity or anterior neck regionmay be performed. Once access to the target location is confirmed, adilator may be used with the guidewire to enlarge the insertion pathway.Then, an introducer or cannula may be inserted over the guidewire,followed by subsequent guidewire removal and insertion of an endoscopeinto the introducer or cannula. Alternatively, an endoscope may beinserted over the guidewire. The endoscope may be manipulated or steeredto directly visualize and identify the relevant structures such as thedisc, the nerve or other adjacent structures and site(s) of tissueremoval. In some embodiments where the patient is under local orregional anesthesia, the suspected nerve impingement may be confirmed bycontacting or manipulating the suspected nerve with the endoscope, orother device inserted through the endoscope, and assessing the patient'sresponse or symptoms. One embodiment of an endoscope that may be used isdescribed in U.S. Application No. 61/045,919, which has been herebyincorporated by reference in its entirety. Once the target region hasbeen evaluated, a tissue removal device may be inserted through thespinal access device or endoscope and to pierce through the annular wallof a herniated disc. Once inserted, the tissue removal device ismanipulated the elongate member to its extended or deployedconfiguration and actuated to emulsify or pulverize the tissue of thenucleus fibrosus. In some embodiments, the tissue removal device may beactuated for a duration in the range of about 5 seconds to about 90seconds or more, sometimes about 15 seconds to about 60 seconds, andother times about 30 seconds to about 60 seconds. The pulverizedmaterial may then be suctioned through the device and then the effect ofthe tissue removal may be reevaluated by the endoscope or othervisualization mechanisms. In some embodiments, a liquid or lubricant maybe injected or infused into the treatment site. In some examples, theliquid or lubricant may be useful to facilitate removal of thepulverized material, including but not limited to vertebral discs thatmay be desiccated. In other examples, the liquid or lubricant may beinjected or infused before or during the actuation of the tissue removaldevice. In some examples, the liquid or lubricant may comprise acontrast agent that may facilitate viewing of the tissue site onfluoroscopy, x-ray, CT, MRI, ultrasound or other imaging modalities. Thecontrast agent may be used at any time or at multiple times during theprocedure, including but not limited to confirmation of guidewire ortissue removal device placement, and also to verify the volume and/orlocation of tissue removal. In some specific embodiments, actuation ofthe tissue removal device may be stopped to verify that annulus of thevertebral disc or the cortical bone of the vertebral body has not beencompromised. Also, in some examples, the contrast agent may be injectedand imaged after device to assess proper operation of the device,including but not limited to tissue pulverization and aspirationmechanisms.

During actuation, the tissue removal device may be held in place or maybe moved around the treatment site. The movement may include moving thedevice back and forth along its insertion access, side to side, up anddown, or with an orbital motion (clockwise or counterclockwise), or anycombination thereof. The range of cable displacement from the rotatableshaft may also be cyclically varied during device actuation. The cyclingmovements may be performed based upon tactile feedback or rotationalresistance of the device, or may be done in repeating motion with anaverage frequency in the range of about one complete motion about every0.5 sec to about 4 seconds, about 1 second to about 2 seconds, or about0.5 seconds to about 1.5 seconds, for example. The duration of eachcycling period may be in the range of about 1 second to about 30 secondsor more, about 3 seconds to about 20 seconds, about 5 seconds to about10 seconds, for example. Suction or aspiration may be applied duringthese motions to assess the amount of tissue pulverized and removed.

The actuation of the tissue removal device may be repeated as desired toremove disc material. In some embodiments, the tissue removal device maybe withdrawn from the disc and reinserted directly into or against theextruded disc material and actuated. Once the tissue removal iscompleted, the tissue removal device may be withdrawn. The puncture sitein the annular wall may have a cross-sectional area of less than about 2mm² or less, sometimes about 1 mm² or less, and other times about 0.9mm² or less, and thus may self-seal without requiring treatment of thepuncture location with an adhesive, a suture or coagulation probe. Thebody location may be rechecked with the endoscope or spinal accessdevice to verify that no bleeding or comprise of the integrity of thedisc or spinal nerves has occurred, and then the endoscope or spinalaccess device is removed from the body and the skin access site isbandaged.

While the embodiments described above may be used to remove soft tissuewithout substantially removing calcified or bony tissue, in otherembodiments, the tissue removal device may be configured to remove bone.In some examples, this may include configuring the tissue removal devicevarious bone-removing coatings and/or a higher rotational speed. Thecoatings may comprise coarser grit structures made from materialsincluding, but not limited to titanium nitride, chrome alloy coating,tungsten carbide, diamond grits, silicon carbide grits, ceramics, orother suitable materials. The spiral cable may be spun at high speed(e.g. about 10,000 rpm to about 30,000 rpm or more) to grind the bone tosmaller pieces that can be aspirated by the auger. Saline irrigation maybe used to clean and/or cool the spiral cable and/or the surroundtissue. In some further configurations, the tissue removal device may befurther configured to differentially removing cancellous bone whilegenerally preserving compact bone. Such a tissue removal device may beused, for example, to form a passageway or cavity within a vertebralbody or a long bone without disrupting the integrity of the outersurface of the bony structure.

In one example, a hollow needle or trocar may be passed through thespinal muscles until its tip is precisely positioned within thefractured vertebra. This may be performed under external imagingguidance (e.g. fluoroscopy, CT or ultrasound) or using an endoscopysystem. In other examples, intraosseous venography may be performed inconjunction with other visualization modalities. In some instances,intraosseous venography may be used to visualize the basivertebralvenous plexus or a paravertebral vein and to possibly avoid inadvertententry into these structures.

Upon reaching the outer surface of the vertebral body, the distal tip ofthe tissue removal device (e.g. the distal head 336 of the tissueremoval device 300 in FIG. 8) may be used to penetrate the compact boneof the vertebral body to provide access to its interior. In otherembodiments, a bone penetration device, such as a trephine or a burr,may be used to form a channel or passageway into the vertebral body. Thebone penetration device is then removed and the cable-based tissueremoval device may be inserted into the passageway and into thevertebral body. In other embodiments, the tissue removal device may beprovided with a distal burr or drill head rather than a conical head. Insome examples, the spiral cable is displaced radially outward before therotating is initiated, while in other examples, rotation is initiatedfirst before the spiral cable it let out. In some examples ofvertebroplasty, the spiral cable may have a maximum radial displacementof about 4 mm, about 5 mm, about 6 mm, about 7 mm, or about 10 mm ormore. In some examples, the volume of space formed by the tissue removaldevice may be further augmented similar to the range of tissue removaldisclosed for removal of annular tissue depicted in FIGS. 20A and 20B.As mentioned previously, the spiral cable may be rotated in thedirectional sense as the spiral configuration, but may also be rotatedin the opposite direction.

The spiral cable may be as a single filament or a multi-filament cable.Each filament may comprise the same or a different material orconfiguration. In some examples, each filament comprises stainless steel(e.g. 304, 316 or 17-4 stainless steel) which is wound into a cable. Thestiffness of the cable may be altered by the changing the tightness ofthe winding, the number of filaments, and/or the thickness of thefilaments. One or more of these characteristics, in combination with anoptional grit surface may be used to adjust the preferential grindingfeatures of the tissue removal device. In some procedures, bypreferentially cutting the cancellous bone while preserving the compactbone, the compact bone shell or structure of the vertebrae or other bonemay protect the soft tissue structures located outside the shell orsurface. The compact bone shell or structure may also restrict flow ofany bone cement injected into the target site. In some examples,contrast dye or other visualization agents may be injected into thetarget site to assess the integrity of the target site prior to cementinjection or other treatments.

In another example, depicted in FIGS. 21A to 21D and FIG. 22, the tissueremoval system 700 may comprise an extendable spiral cable 702 with ablunt distal tip 704. In some instances, a blunt distal tip 704 may beused when a passageway or channel has been previously formed, or whenblunt dissection is sufficient. For example, during a discectomy or avertebroplasty procedure, a cannula 706 containing a removable obturatorwith sharp distal end 708, as shown in FIG. 23, may be used to form apassageway or channel through the tissue surrounding the spine and/orthrough the surface of a vertebra. The obturator may be removed from thecannula 706 to insert the tissue removal system 700. In other examples,a trocar with a sharp distal end may be used to form a passageway andthen removed to permit insertion of the tissue removal system 700.Alternatively, a trephine or bone burr, which may be either motorized ormanually activated, may be used with the cannula 706, in addition to orin lieu of the obturator. The cannula 706 may comprise an optionalproximal connector 709, such as Luer lock, to releasably couple theobturator and/or the tissue removal system 700.

Referring to FIG. 21A, which depicts the spiral cable 702 in an extendedposition, and to FIGS. 21B to 21D, which depicts the spiral cable 702 ina retracted position, the cable 702 is attached distally to the bluntdistal tip 704 and proximally to a base 710. The cable 702 may bepartially recessed in channels 712 and 714 of the tip 704 and base 710.Between the tip 704 and base 710 is a cable shaft 716 with across-sectional size that is smaller than the tip 704 and/or base 710.In other embodiments, the cable shaft may have a cross-sectional sizethat is similar to or greater then the tip 704 or base 710. The cableshaft may also comprise an optional groove or recess to at leastpartially retain the cable 704 when in a retracted position.

FIGS. 21A to 21D further depict an optional feature of the tissueremoval system 700 comprising an outer tubular shaft 718 with a cuttingedge 720. In this particular example, the cutting edge 720 is a bevelededge, which may or may not be at least partially sharpened. In otherexamples, the cutting edge may be sharpened but not beveled. As furtherdepicted in FIGS. 21A to 21D, the inner shaft 722 located in the outertubular shaft 718 may comprise at least one optional thread structure724 which is configured to draw fluids and/or other materials into theouter tubular shaft 718 for removal from the target site. A beveled orsharpened edge may further shear or break-up materials pulled into theouter tubular shaft 718 by the thread structure 724. In some examples,the rotational sense of the thread structure 724 may be the same as thespiral cable 702, but in other examples, the thread structure 724 andthe spiral cable 702 may be opposite rotational senses.

The thread structure 724 may be made from the same or a differentmaterial as the inner shaft 722 and/or the outer tubular shaft 718. Insome examples, use of a different material between the thread structure724 and the outer tubular shaft 718 may reduce or eliminate gallingeffects from the relative rotation between the two structures. In someinstances, galling may generate dark or black materials that may pigmentthe pulverized material. This pigmentation may interfere with variousanalyses of the pulverized material, and/or the ability of the user toassess heat-related effects of the tissue removal device on thepulverized tissue. In one specific example, the outer tubular shaft 718may comprise 304 stainless steel while the thread structure 724 maycomprise 17-4 stainless steel. The thread structure 724 may beintegrally formed with the inner shaft 722, e.g. grounded or formed froma base hypotube structure, but in other examples the thread structure724 may be attached to the inner shaft 722 by welding, adhesives orother attachment processes. For example, the thread structure 724 maycomprise a coiled stainless steel or Parylene wire that may be attachedusing epoxy along its entire length to the inner shaft 722 or may beattached at certain locations, e.g. the proximal end and the distal endof the thread structure 724. In some instances, partial attachment ofthe thread structure 724 to the shaft 722 may permit greater flexion orother deformation of that section of the tissue removal system 700 bypermitting greater tensile or compressive strain in the thread structure724 compared to the inner shaft 722. This greater flexion may alsoreduce heat generation between the thread structure 724 and inner shaft722.

FIG. 25 schematically depicts another example of a cutting mechanismwhere instead of a cutting edge 720 located at the distal opening of theouter tubular shaft 718 as depicted in FIGS. 21A to 21D, the tissueremoval system may comprise an internal cutting or grinding mechanism750. This mechanism comprises an outer tubular shaft 752 with an innercutting or grinding structure 754 that protrudes into the inner lumen756 of the outer tubular shaft 752 and cooperates with a circumferentialgroove or recess 758 on the inner tubular shaft 760 to morcellize, cutor otherwise breakdown any larger tissue fragments that may enter theouter tubular shaft 752. The inner cutting structure 754 may have any ofa variety of configurations, including different rake angles and/orsurface configurations. The configuration of the recess 758 on the innertubular shaft 760 may vary in width and cross-sectional shape. Althoughonly a single internal mechanism 750 is depicted, in other examples,multiple mechanisms may be provided along the shafts 752 and 760. Insome further examples, an internal mechanism 750 may be used with thetip-based mechanism illustrated in FIGS. 21A to 21D.

FIG. 22 further depicts another optional feature of a tissue removalsystem 700, comprising an optically transparent chamber 726. Althoughthe optically transparent chamber section 726 in FIG. 22 is locateddistally at the attachment of the outer tubular shaft 718, in otherexamples, the optically transparent housing chamber 726 may be locatedat a more proximal location. The optically transparent housing section726 comprises an optically clear passageway or cavity in communicationwith the lumen of the outer tubular shaft 718 so that any fluid and/ormaterials either injected distally or removed proximally may be viewedby the user. In some instances, the passageway or cavity may have avolume of at least about 0.5 cc, sometimes about 1 cc, and other timesabout 2 cc or more. The optically transparent housing chamber 726 mayalso comprise markings to identify the volume of material that hasaspirated or prepared for infusion or irrigation, for example. Theoptically transparent chamber 726 may also features a removable cap toempty the contents for of the chamber 726, to reduce clogging or tocollect a diagnostic tissue sample. In some examples, the tissue removalsystem may have one or more infusion lumens with one or more openings atthe base, cable shaft, and/or distal tip of the tissue removal system,which may be used in addition to or in lieu distal end of the outertubular shaft 718. In other examples, the tissue removal system may beremoved from the vertebral body and a separate infusion instrument maybe used to deliver therapeutic agents or materials.

In use, the tissue removal system 700 depicted in FIGS. 21A to 22 may beused for any of a variety of tissue removal procedures, includingdiscectomy and vertebroplasty, depending upon the particularconfiguration. Referring to FIGS. 24A and to 24C, a vertebral body 730may be accessed by any of a variety of access procedures describedherein. A tissue removal system 700 (with a shaft 718—not drawn toscale) may be inserted into the interior of the vertebral body (FIG.24A) and then rotated with the cable 702 extended to form a cavity 732in the vertebral body 730 (FIG. 24B). The tissue removal system 700 maybe further manipulated until adequate removal of cancellous bone isachieved. As shown in FIG. 24C, the tissue removal system 700 may beloaded with a bone cement 734 which is then delivered to the cavity 732.In some examples, the bone cement 734 may comprise a material such aspolymethyl methacrylate hydroxyapatite, or any of a variety of otherbone cements or other hardenable or curable substances can be injectedthrough the trocar to fill the cavity created by the by the tissueremoval system 700. The cable 702 of the tissue removal system 700 maybe retracted or extended during delivery of therapeutic agents. In someinstances, the extended cable 702 may redistribute the therapeuticagents against the cavity walls, which may reduce the risk of leakageout of the cavity.

In some of the procedures described above, the cavity in the vertebralbody is formed before the delivery of therapeutic agents, but in otherprocedures, the delivery of therapeutic agents may occur simultaneously.In procedure where the cavity is first formed, filling of the emptycavity may reduce initial filling pressures. In some instances, lowerfilling pressures may reduce the risk of leakage. In some examples, thetissue removal system may comprise a pressure sensor which may be usedby the user or may be configured automatically to shut off delivery orpressurization of the therapeutic agents upon reaching a particularpressure limit.

Although some of the examples described herein are directed to treatmentof vertebral disc fractures, in other examples, the tissue removalsystems may be used to treat or diagnose bone lesions located in thevertebrae or other bones of the body. Diagnosis of bone lesions mayinclude biopsy of bone. These bone lesions may include but are notlimited to potentially cancerous bone lesions, including osteomas,osteosarcomas and metastatic lesions, as well as potentially infectiousbone lesions, including tuberculosis. Bone cement, with or without othertherapeutic agents such as anti-neoplastic and anti-infective agents,may or may not be injected into the

It is to be understood that this invention is not limited to particularexemplary embodiments described, as such may, of course, vary. It isalso to be understood that the terminology used herein is for thepurpose of describing particular embodiments only, and is not intendedto be limiting, since the scope of the present invention will be limitedonly by the appended claims.

Where a range of values is provided, it is understood that eachintervening value, to the tenth of the unit of the lower limit unlessthe context clearly dictates otherwise, between the upper and lowerlimits of that range is also specifically disclosed. Each smaller rangebetween any stated value or intervening value in a stated range and anyother stated or intervening value in that stated range is encompassedwithin the invention. The upper and lower limits of these smaller rangesmay independently be included or excluded in the range, and each rangewhere either, neither or both limits are included in the smaller rangesis also encompassed within the invention, subject to any specificallyexcluded limit in the stated range. Where the stated range includes oneor both of the limits, ranges excluding either or both of those includedlimits are also included in the invention.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. Although any methods andmaterials similar or equivalent to those described herein can be used inthe practice or testing of the present invention, some potential andpreferred methods and materials are now described. All publicationsmentioned herein are incorporated herein by reference to disclose anddescribe the methods and/or materials in connection with which thepublications are cited. It is understood that the present disclosuresupersedes any disclosure of an incorporated publication to the extentthere is a contradiction.

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural referents unless thecontext clearly dictates otherwise. Thus, for example, reference to “ablade” includes a plurality of such blades and reference to “the energysource” includes reference to one or more sources of energy andequivalents thereof known to those skilled in the art, and so forth.

The publications discussed herein are provided solely for theirdisclosure. Nothing herein is to be construed as an admission that thepresent invention is not entitled to antedate such publication by virtueof prior invention. Further, the dates of publication provided, if any,may be different from the actual publication dates which may need to beindependently confirmed.

1.-22. (canceled)
 23. A system, comprising: a rotatable shaft assemblycomprising a distal coupling site and a proximal coupling site, theproximal coupling site having a proximal surface opening; and a flexibleelongate member comprising a distal section and a proximal section, thedistal section coupled to the distal coupling site of the rotatableshaft assembly and the proximal section slidably positioned in theproximal surface opening, wherein the flexible elongate member has aretracted configuration and an extended configuration and a distancebetween the distal coupling site and the proximal coupling site remainssubstantially the same as the flexible elongate member transitions fromthe retracted configuration to the extended configuration.
 24. Thesystem of claim 23, wherein the flexible elongate member comprises aflexible multi-filament elongate member.
 25. The system of claim 24,where the flexible multi-filament elongate member comprises no more thanten filaments.
 26. The system of claim 23, wherein the distal couplingsite includes a distal surface opening and the rotatable shaft assemblyfurther comprises a groove extending between the proximal surfaceopening and the distal surface opening.
 27. The system of claim 26,wherein the groove is a helical groove.
 28. The system of claim 27,wherein the helical groove has a variable pitch.
 29. The system of claim23, wherein the elongate member includes a middle section between thedistal section and the proximal section, a perpendicular distancebetween the middle section of the flexible elongate member and therotatable shaft assembly is greater in the extended configuration thanin the retracted configuration.
 30. The system of claim 29, wherein theperpendicular distance between the middle section of the flexibleelongate member and the rotatable shaft assembly in the extendedconfiguration is equal to or greater than about the average diameter ofthe rotatable shaft assembly.
 31. The system of claim 30, wherein theperpendicular distance between the middle section between the middlesection of the flexible elongate member and the rotatable shaft assemblyin the extended configuration is equal to greater than about twice theaverage diameter of the rotatable shaft assembly.
 32. The system ofclaim 23, wherein the rotatable shaft assembly comprises a distalpenetrating tip.
 33. The system of claim 23, wherein the length of theflexible elongate member outside of the rotatable shaft assembly isdifferent in the retracted configuration and the extended configuration.34. The system of claim 23, wherein the distance between the distalcoupling site and the proximal surface opening is unchanged in theretracted configuration and the extended configuration.
 35. The systemof claim 23, wherein the flexible elongate member comprises at least onerigid section and at least one flexible section.
 36. The system of claim35, wherein the flexible elongate member comprises at least two rigidsections.
 37. The system of claim 35, wherein at least one rigid sectionis a linear rigid section.
 38. The system of claim 36, wherein theflexible elongate member comprises a proximal rigid rod and a distalrigid rod interconnected by a flexible cable.
 39. The system of claim38, wherein the proximal rigid rod is located in the proximal surfaceopening.
 40. The system of claim 39, wherein the proximal rigid rod islocated in the proximal surface opening when the flexible elongatemember is in the extended configuration.
 41. The system of claim 23,wherein at least a portion of the flexible elongate member comprises agrit surface with an average grit number in the range of about 200 toabout
 500. 42. The system of claim 23, wherein the rotatable shaftassembly is coupled to a motor by a bendable driveshaft.
 43. The systemof claim 42, further comprising a steering assembly configured to bendthe driveshaft.
 44. The system of claim 23, wherein the flexibleelongate member comprises a polymeric coating.
 45. The system of claim44, wherein the polymeric coating comprises polyimide.